Early, active relapsing remitting Multiple Sclerosis (RRMS)
Conditions
Interventions
Trade Name: Mitoxantrone
Product Name: Mitoxantrone
Pharmaceutical Form:
Trade Name: Copaxone
Product Name: Glatiramer Acetate
Sponsors
The Walton Centre for Neurology and Neurosurgery
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Definite MS as determined by the McDonald criteria (Ann Neurol, July 2001) with relapsing remitting disease course, clinical status should be stable or improving for 1 month prior to screening. Patients 18 to 55 years of age with disease duration less than 5 years from onset, who had 2 relapses in the last 2 years and EDSS 0 – 5.5. and At least 3 of the following: a)Patients with three or more relapses in the first two years of disease b)Motor involvement in early relapses (weakness/ataxia) c)Incomplete recovery from early relapses (EDSS >1.5) d)10 or more lesions on T2-weighted brain MRI Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a)Patients ever treated with GA, Mitoxantrone or Interferons. b)Patients treated with IV immunoglobulins (IVIg) in the 4 weeks prior to screening visits. c) Patients treated with methotrexate or azathioprine in the previous 6 monthsprior to screening visits. d) Patients ever treated with cyclophosphamide, Total Lymphoid Irradiation(TLI), or cladribine for injection or anthracenediones or anthracyclines, or prior mediastinal radiotherapy. e) Patients treated with IV or oral steroids within 30 days of screening visit f) Pregnant or lactating women at the screening visit. g) Left ventricular ejection fraction (LVEF) 150% upper limit of normal (normal = 11.5 – 15.5 secs.) l) Patients with any medical or psychiatric conditions that would make the patient unsuitable for this research, as determined by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Annualised Relapse Rate (ARR) - the number of relapses per year over a 36 month period Relapse free patients Time to first relapse Time to withdrawal ; Primary end point(s): Primary Endpoints: Multiple Sclerosis Impact Scale (MSIS) Expanded Disability Status Scale (EDSS) ; Main Objective: Does sequential treatment with Mitoxantrone and Glatiramer Acetate (Copaxone) vs. Interferon Beta in early active relapsing remitting Multiple Sclerosis lead to better patient outcomes (in terms of the reduced relapses, reduced disability and improved quality of life)? | — |
Countries
United Kingdom
Outcome results
None listed